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Recent Articles

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FDA starts priority review of Eli Lilly’s donanemab injectable Alzheimer drug designed to clear amyloid plaque from brain; late-stage study results expected by middle of 2023

Novartis cancels filing for FDA approval of tislelizumab to treat non-small cell lung cancer after FDA decision to delay review of drug as esophageal squamous cell carcinoma treatment; Novartis paid BeiGene US$650M for rights to drug outside China

FDA starts priority review of Roche’s injectable Lunsumio mosunetuzumab to treat relapsed or refractory follicular lymphoma, a type of blood cancer; in June, Lunsumio received approval for use in the EU

FDA accepts priority review of Regeneron and Sanofi’s sBLA for Dupixent Medical dupilumab injectable to treat adults with prurigo nodularis; if approved, Dupixent would be only drug to treat prurigo nodularis in US

FDA suspends early-stage clinic trial of Vertex’s VX-880 stem-cell therapy to potentially cure type 1 diabetes for ‘insufficient information’ to approve increased dose in tests; Vertex hopes continuing studies in Canada will assuage FDA concerns

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